FOR-A Diamond PRIMA User manual

Owner’s Manual
Blood Glucose Monitoring System
PRIMA

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Dear FORA Diamond PRIMA
System Owner:
Thank you for purchasing the FORA Diamond PRIMA Blood Glucose
Monitoring System. This manual provides important information to help
you to use the system properly. Before using this product, please read the
following contents thoroughly and carefully.
Regular monitoring of your blood glucose levels can help you and your
doctor gain better control of your diabetes. Due to its compact size and
easy operation, you can use the FORA Diamond PRIMA Blood Glucose
Monitoring System to easily monitor your blood glucose levels by yourself
anywhere, any time.
If you have other questions regarding this product, please contact the
place of purchase or call the Customer Care Line.
Version 2.0 2012/06
311-4281100-005
English

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IMPORTANT SAFTY INSTRUCTIONS READ
BEFORE USE
1. Use this device ONLY for the intended use described in this manual.
2. Do NOT use accessories which are not specified by the manufacturer.
3. Do NOT use the device if it is not working properly or if it is
damaged.
4. Do NOT use the equipment in places where aerosol sprays are
being used or where oxygen is being administered.
5. Do NOT under any circumstances use the device on newborns or
infants.
6. This device does NOT serve as a cure for any symptoms or diseases.
The data measured is for reference only.
7. Before using this device to test blood glucose, read all instructions
thoroughly and practice the test. Carry out all the quality control
checks as directed.
8. Keep the device and testing equipment away from young children.
Small items such as the battery cover, batteries, test strips, lancets
and vial caps are choking hazards.
9. Use of this instrument in a dry environment, especially if synthetic
materials are present (synthetic clothing, carpets etc.) may cause
damaging static discharges that may cause erroneous results.
10. Do NOT use this instrument in close proximity to sources of strong
electromagnetic radiation, as these may interfere with the accurate
operation.
KEEP THESE INSTRUCTIONS IN A SAFE PLACE

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TABLE OF CONTENTS
BEFORE YOU BEGIN 06
Important Information 06
Intended Use 07
Test Principle 07
Meter Overview 08
Display Screen 09
Test Strip 10
Setting the Meter 11
THE FOUR MEASURING MODES 14
Control Solution Testing 15
Performing a Control Solution Test 15
TESTING WITH BLOOD SAMPLE 18
Preparing the Puncture Site 18
Alternative Site Testing 20
Performing a Blood Glucose Test 21
METER MEMORY 24
Reviewing Test Results 24
Reviewing Blood Glucose Day Average Results 25
Downloading Results onto a Computer 26
MAINTENANCE 27
Battery 27
Caring for Your Meter 28
Caring for Your Test Strips 29
Important Control Solution Information 30
SYSTEM TROUBLESHOOTING 31
Result Readings 31
Error Messages 32
Troubleshooting 33
DETAILED INFORMATION 34
SYMBOL INFORMATION 35
SPECIFICATIONS 36

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BEFORE YOU BEGIN
Important Information
●Severe dehydration and excessive water loss may cause readings
which are lower than actual values. If you believe you are suffering
from severe dehydration, consult a healthcare professional
immediately.
●If your blood glucose results are lower or higher than usual, and you
do not have any symptoms of illness, first repeat the test. If you have
symptoms or continue to get results which are higher or lower than
usual, follow the treatment advice of your healthcare professional.
●Use only fresh whole blood samples to test your blood glucose. Using
other substances will lead to incorrect results.
●If you are experiencing symptoms that are inconsistent with your blood
glucose test results and you have followed all the instructions given in
this ownerʼs manual, contact your healthcare professional.
●We do not recommend using this product on severely hypotensive
indi viduals or patients in shock. Readings which are lower than actual
values may occur for individuals experiencing a
hyperglycaemic-hyperosmolar state, with or without ketosis. Please
consult the healthcare professional before use.
●The measurement unit used for indicating the concentration of blood
or plasma glucose can either have a weight dimension (mg/dL) or a
molarity (mmol/L). The approximate calculation rule for conversion of
mg/dL in mmol/L is:
For example;
1) 120 mg/dL ÷18 = 6.6 mmol/L
2) 7.2 mmol/L x 18 = 129 mg/dL approximately.
mg/dL
mmol/L
Divided by 18
Times 18
= mmol/L
= mg/dL

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Intended Use
This system is intended for use outside the body (in vitro diagnostic
use) by people with diabetes at home and by health care professionals
in clinical settings as an aid to monitoring the effectiveness of diabetes
control. It is intended to be used for the quantitative measurement of
glucose (sugar) in samples of venous whole blood and fresh capillary
whole blood (from the finger, palm, forearm, upper arm, calf and thigh). It
should not be used for the diagnosis of diabetes, or testing on newborns.
Professionals may test with capillary and venous blood sample; home
use is limited to capillary whole blood testing. Use only heparin for
anticoagulation of whole blood.
Test Principle
Your system measures the amount of sugar (glucose) in whole blood.
The glucose testing is based on the measurement of electrical current
generated by the reaction of glucose with the reagent of the strip. The
meter measures the current, calculates the blood glucose level, and
displays the result. The strength of the current produced by the reaction
depends on the amount of glucose in the blood sample.

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Meter Overview
Test Slot
Insert test strip here to turn the meter on for testing.
Test Strip Ejector
Eject the used strip by pushing up this button.
Display Screen
Main Button
Enter the meter memory and silence a reminder alarm.
Data Port/USB
Download test results with a cable connection.
SET Button
Enter and confirm the meter settings.
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1
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5
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Display Screen
Test Result
Ketone Warning
Warning Symbol
Testing Mode Symbol
Memory Symbol
Control Solution Mode
Date
Time
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2
3
5
4
6
7
8
Day Average
Alarm Symbol
Face/Low/High Symbol
Measurement Unit
Low Battery Symbol
Test Strip Symbol
Blood Drop Symbol
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ATTENTION:
The front side of test strip should face up when
inserting test strip.
Test results might be wrong if the contact bar is not fully
inserted into the test slot.
NOTE:
The FORA Diamond PRIMA monitor should only be used with FORA Diamond
PRIMA Test Strips. Using other test strips with this meter can produce inaccurate
results.
Test Strip
Test Strip Handle
Hold this part to
insert the test strip
into the slot.
Confirmation Window
This is where you confirm
if enough blood has been
applied to the absorbent
hole in the strip.
Contact Bars
Insert this end of the test
strip into the meter. Push
it in firmly until it will go
no further.
Absorbent Hole
Apply a drop of blood
here. The blood will be
automatically absorbed.

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Entering the Setting Mode
Start with the meter off (no test strip
inserted). Press SET.
1. Setting the date
With the year flashing, press Main button
until the correct year appears. Press SET.
With the month flashing, press Main
button until the correct month appears.
Press SET.
With the day flashing, press Main button
until the correct day appears. Press SET.
2. Setting the time format
Press Main button to select the desired
time format --- 12h or 24h. Press SET.
Setting the Meter
Before using your meter for the first time or if you change the meter
battery, you should check and update these settings. Make sure you
complete the steps below and have your desired settings saved.

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5. Setting the reminder alarm
You may set up any or all of the reminder
alarms (1-4). The meter displays “On”or
“OFF”and “”, press Main button to
turn on or turn off to set the first reminder
alarm.
Press Main button to select “On”, then
press SET to set the hour. When the hour
is flashing, press Main button to add an
3. Setting the time
With the hour flashing, press Main button
until the correct hour appears. Press SET.
With the minute flashing, press Main
button until the correct minute appears.
Press SET.
4. Deleting the memory
With “dEL”and a flashing “”on the
display, press Main button and select “no”
to keep the results in memory then press
SET to skip.
To delete all the results, press Main
button and “yes”and “”are displayed
on the meter, press SET to delete the
memory.

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hour. Press SET to confirm and go to
minutes, press Main button to add one
minute. Hold Main button longer to add
faster. Press SET to confirm and go to the
next alarm setting.
If you do not want to set an alarm, press
SET to skip this step.
If you want to turn off an alarm, find
the alarm number by pressing SET in
the setting mode, press Main button to
change from “ON”to “OFF”.
At the time of your alarm, the meter will beep and automatically turn on.
You can press Main button to silence the alarm and insert a test strip to
begin testing. If you do not press Main button, the meter will beep for 2
minutes then switch off. If you do not want to test at this time, press Main
button to switch off the meter.
Congratulations! You have completed all settings!
NOTE:
•These parameters can ONLY be changed in the setting mode.
•If the meter is idle for 3 minutes during the setting mode, it will switch off
automatically.

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You can switch between each mode by:
1. Start with the meter switched off.
Insert a test strip to turn on the meter.
The screen will display a flashing “”
and “Gen”.
THE FOUR MEASURING MODES
The meter provides you with four modes for measuring, General, AC, PC
and QC.
MODES
General
(displays as “Gen”)
AC
PC
QC
USE WHEN
any time of day without regard to time since last
meal
no food intake for at least 8 hours
2 hours after a meal
testing with the control solution
2. Press Main button to switch between
General, AC, PC and QC mode.

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Control Solution Testing
Our Control Solution contains a known amount of glucose that reacts with
test strips and is used to ensure your meter and test strips are working
together correctly.
Test strips, control solutions, or sterile lancets may not be included in
the kit (please check the contents on your product box). They can be
purchased separately. Please make sure you have those items needed for
a blood glucose test beforehand.
Do a control solution test when:
●you first receive the meter,
●at least once a week to routinely check the meter and test strips,
●you begin using a new vial of test strips,
●you suspect the meter or test strips are not working properly,
●your blood glucose test results are not consistent with how you feel, or
if you think the results are not accurate,
●practicing the testing process, or
●you have dropped or think you may have damaged the meter.
Performing a Control Solution Test
You will need:
Meter
1Test Strip 2Control Solution 3

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2. Press Main button to mark this test
as a control solution test
With “”displayed, the meter will not
store your test result in memory. If you
press the Main button three times, the
“”will disappear and this test is no
longer a control solution test.
WARNING:
When doing the control solution test, you have to mark it so that the test result
will NOT mix with the blood glucose TEST RESULTS stored in the memory. Failure
to do so will mix up the blood glucose test results with the control solution test
results in memory.
1. Insert the test strip to turn on the
meter
Insert the test strip into the meter. Wait
for the meter to display “”and “”.

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NOTE:
•The control solution range printed on the test strip vial is for control
solution use only. It is not a recommended range for your blood glucose level.
•See the Meter Maintenance section for important information about your
control solutions.
Out-of-range results
If you continue to have test results fall outside the range printed on the
test strip vial, the meter and strips may not be working properly. Do NOT
test your blood. Contact the local customer service or place of purchase
for help.
4. Read and compare the result
After counting down to 0, the control
solution test result will appear on the
display. Compare this result with the
range printed on the test strip vial and it
should fall within this range. If not, please
read the instructions again and repeat
the control solution test.
(112 mg/dL = 6.2 mmol/L; 100−165
mg/dL = 5.6−9.2 mmol/L)
3. Apply control solution
Shake the control solution vial thoroughly before use. Squeeze out a
drop and wipe it off, then squeeze out another drop and place it on the
tip of the vial cap. Hold the meter to move the absorbent hole of the test
strip to touch the drop. Once the confirmation window fills completely,
the meter will begin counting down. To avoid contaminating the control
solution, do not directly apply control solution onto a strip.
100~165

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TESTING WITH BLOOD SAMPLE
Preparing the Lancing Device for Blood Testing
Please follow the instructions in the lancing device insert for collecting a
blood sample.
WARNING:
To reduce the chance of infection:
•Never share a lancet or the lancing device.
•Always use a new, sterile lancet. Lancets are for single use only.
•Avoid getting hand lotion, oils, dirt, or debris in or on the lancets and the
lancing device.
Preparing the Puncture Site
Stimulating blood perfusion by rubbing the puncture site before blood
extraction has a significant influence on the glucose value obtained.
Blood from a site that has not been rubbed exhibits a measurably
different glucose concentration than blood from the finger. When the
puncture site was rubbed prior to blood extraction, the difference was
significantly reduced.
Please follow the suggestions below before obtaining a drop of blood:
●Wash and dry your hands before starting.
●Select the puncture site either at fingertips or another body parts
(please see section “Alternative Site Testing”(AST) on how to select the
appropriate sites).
●Clean the puncture site using cotton moistened with 70% alcohol and
let it air dry.
●Rub the puncture site for about 20 seconds before penetration.
●Use a clear cap (included in the kit) while setting up the lancing device.

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●Fingertip testing
Press the lancing deviceʼs tip firmly
against the lower side of your fingertip.
Press the release button to prick your
finger, then a click indicates that the
puncture is complete.
●Blood from sites other than the
fingertip
Replace the lancing device cap with the
clear cap for AST. Pull the cocking control
back until it clicks. When lancing the
forearm, upper arm, hand, thigh, or calf,
avoid lancing the areas with obvious veins
because of excessive bleeding.
NOTE:
•Choose a different spot each time you test. Repeated punctures at the same
spot may cause soreness and calluses.
•Please consult your health care professional before you begin AST.
•It is recommended that you discard the first drop of blood as it might contain
tissue fluid, which may affect the test result.
1
2

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Alternative Site Testing
You can test on a variety of locations
on your body.
Important:
There are limitations with AST (Alternative Site Testing).
Please consult your health care professional before you perform AST.
Suggested Test Areas
for the Hand
Forearm
Upper Arm
Thigh
Calf
When to use AST?
Capillary blood at the fingertip reflects these changes faster than
capillary blood at other sites. Thus, when testing blood glucose during or
immediately after a meal, physical exercise, or any other event, take a
blood sample from your finger only.
We strongly recommend that you perform AST ONLY at the following
times:
●In a pre-meal or fasting state (more than 2 hours since the last meal).
●Two hours or more after taking insulin.
●Two hours or more after exercise.
Do NOT use AST if:
●You think your blood glucose is low.
●You are unaware of hypoglycemia.
●You are testing for hyperglycemia.
●Your AST results do not match the way you feel.
●Your routine glucose results often fluctuate.